15 days old

QC Lab Manager (Systems)

Pfizer
Tunas, MO 65764
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**Why Patients Need You**



Everything we do, every day, is in line with an unwavering commitment to the quality and the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is flexible, innovative, and customer oriented. Whether you are involved in development, maintenance, compliance or analysis through research programs, your contribution will directly impact patients.



**What You Will Achieve**



You will be a member of Pfizer's dedicated and highly effective quality assurance and control team. You will be responsible for analyzing chemical, biological or microbiological products to support our quality programs. Your contribution to environmental testing, utility monitoring, analytical testing, microbial identification and sterility testing will help Pfizer provide safe drugs to patients.



Your understanding of Quality Control (QC) instruments will help us meet their accuracy specifications against established standards. You will also be relied on for setting requirements for the transfer of methodology from Research and Development (R&D).



As a Manager, your breadth of knowledge on internal or external business challenges will help us improve our products, processes and services. Your will guide us to lead projects by meeting objectives and preparing forecasts for resource requirements. Your risk-taking ability will help us advance new concepts and methodologies. You will provide technical guidance and oversight to team members and help in problem solving.



It is your dedication that will make Pfizer ready to achieve new milestones and help patients across the globe.



**How You Will Achieve It**



The incumbent will be required to achieve the site quality control objectives and will be responsible for the Quality Control (QC) systems related aspects of all analytical and microbiological testing with the QC laboratory. The incumbent will be responsible for leading, coaching and developing the laboratory system teams and ensure that systems related activities (equipment qualification, preventive maintenance, LIMS, QC projects ) are performed in a safe and reliable manner to support manufacturing operations. The incumbent will ensure that all QC system related activities comply with Good Manufacturing Practices (GMPs), Data Integrity (DI), Pfizer Quality Standards (PQS) policies , site Standard Operating Procedures (SOPs) and regulatory guidance. With excellent verbal, written, and interpersonal communication skills the incumbent will lead a team of QC professionals and will need to be action-oriented and a strong leader for the quality culture of the laboratory. The incumbent will support and stand in for the Senior QC Manager when required.



+ Management of QC system teams to ensure QC projects (e.g. LIMs implementation, Empower CDS custom fields, Data Integrity initiatives) and equipment qualification/decommissioning activities carried out accordingly to Pfizer Quality Standards are completed as per agreed site timelines.

+ Ensure all system related Data integrity activities (e.g. system audit trail review, review of user profile and access) are carried out according to Pfizer Quality Standards and site SOPs.

+ Ensure routine prevent maintenance of laboratory equipment are completed as per schedule and maintain a high level of QC equipment availability to support QC operational testing.

+ Ensure QC operational consumables (HPLC columns, reference standards) are maintained at the right level to support operational testing

+ Ensure QC systems tiers are well managed and quality, operational safety issues, standard works, escalations and non-conformance are tracked to ensure prompt closure on time.

+ Ensure a safe working environment for the laboratory. Lead initiatives to improve safety performance and colleague engagement.

+ Develop , manage and track the operating budget and capital expenditure in QC to ensure achievement of operational targets.

+ Work closely with the relevant process owners on all QC system related activities (e.g. LIMS, specifications and equipment qualification) for the new product introduction into the site.

+ Review and approve QC Operating SOP

+ Support regulatory inspection for all QC system related issues.

+ Oversight of all non-conformance within the QC system team to ensure that investigations carried out are in-depth, consistent in quality and comply with Pfizer PQS and that CAPAs implemented are systematic and effective to address root cause identified.

+ Manage, develop, and motivate staff to help realized their maximum potential to contribute towards achieving the site objectives.

+ Monthly trending of system related activities in QC and presentation to SQRT for any adverse trends



**Qualifications**



**Must-Have**



+ Bachelor's Degree

+ Minimum 7 - 10 years of technical experience in Quality Control within the pharmaceutical, food, chemical or

+ process industries. Additional experience in Quality Assurance is highly desirable.

+ Minimum 5 years in leadership/supervisory position of professional staff previously.

+ Experience in equipment qualification/decommission, LIMS and CDS implementation , Data Integrity remediation actions.

+ Extensive knowledge of GMP compliance requirements for Quality Control laboratories is a must

+ Excellent verbal, written and interpersonal communication skills

+ Demonstrated ability to interact effectively with senior management, QA/QC colleagues, auditor and regulators

+ Thorough knowledge and understanding of GMP, GLP, GDP , Data Integrity and PQS for non-conformance management.

+ Good knowledge of analytical chemistry, instrumentation , laboratory automation and production processes.

+ Good interface with different stakeholders (Production, QC Operations, IMEX) to ensure that CAPA implemented are aligned with operational requirements.



**Nice-to-Have**



+ Master's degree

+ Knowledge in the application of statistical tools, root cause analysis and/or six sigma methodologies.



Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.



Quality Assurance and Control



\#LI-PFE
Posted: 2021-06-02 Expires: 2021-07-03
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QC Lab Manager (Systems)

Pfizer
Tunas, MO 65764

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